Chemoradiotherapy of NSCLC Stage IIIB

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pierre Fabre Laboratories
Ligue contre le cancer, France
Information provided by:
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT00198432
First received: September 13, 2005
Last updated: December 23, 2005
Last verified: December 2005
  Purpose

To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy.


Condition Intervention Phase
NSCLC Stage IIIB
Concomitant Radiochemotherapy
Drug: Paclitaxel, vinorelbine, cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study Evaluating an Induction Chemotherapy Followed by a Concomitant Chemoradiotherapy and a Concomitant Chemoradiotherapy Followed by a Consolidation Chemotherapy Among Patients With NSCLC Stage III Not Resectable

Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:
  • Objective response rate

Secondary Outcome Measures:
  • Overall survival
  • Time to progression
  • Relapse rate (local control)
  • Safety

Estimated Enrollment: 130
Study Start Date: March 2002
Estimated Study Completion Date: December 2006
Detailed Description:

Chemotherapy:

C = Cisplatine : 80 mg/m² P = Paclitaxel : 200 mg/m² N = Vinorelbine : 15 mg/m²

Radiotherapy:

66 Gy with 33 fractions (2 Gy/fraction, 1 fraction/day, 6,5 weeks) High energy Photons X (>= 9MV)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • NSCLC stage IIIA N2 or IIIB not resectable, except N3 sus-clavicular, nor reached pleural
  • PS = 0 or 1
  • Possibility of including all the targets in only one exposure field
  • Slimming < 10% of the weight of the body
  • Functions hepatic, renal and hematologic normal
  • VEMS >40% and PaO2 >60 mmHg
  • written and signed informed consent

Exclusion criteria :

- NSCLC stage IV or wet-IIIB

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198432

Locations
France
CHU Saint-Etienne Pneumologie
Saint-Etienne, France, 42000
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Bristol-Myers Squibb
Pierre Fabre Laboratories
Ligue contre le cancer, France
Investigators
Principal Investigator: Pierre Fournel, Dr IFCT
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00198432     History of Changes
Other Study ID Numbers: IFCT-0201
Study First Received: September 13, 2005
Last Updated: December 23, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on September 18, 2014